Ise Reagents for Olympus Au 800/AU5200 Chemistry Systems
FDA 510(k) K972004 · Alko Diagnostic Corp.
510(k) numberK972004
Submission
- Device name
- Ise Reagents for Olympus Au 800/AU5200 Chemistry Systems
- Applicant
- Alko Diagnostic Corp.
Holliston, MA, US - Received
- May 30, 1997
- Decision date
- June 16, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGZ – Electrode, Ion-Specific, Chloride
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1170
- Specialty
- Clinical Chemistry
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| K162020 | VITROS Chemistry Products Cl- SlidesCGZ · Traditional | Ortho Clinical Diagnostics | 12/16/2016SE |
| K082099 | Vitros Chemistry Products Ci-Dt Slides; Vitros Chemistry Products DT Calibrator Kit…CGZ · Special | Ortho-Clinical Diagnostics, Inc. | 08/21/2008SE |
| K070889 | Autodelfia Neonatal Irt L Kit, Model B022-112CGZ · Traditional | Wallac OY | 04/14/2008SE |
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| K060108 | Cobas Integra Chloride Elctrode GEN.2CGZ · Special | Roche Diagnostics Corp. | 02/16/2006SE |
| K052027 | Opti Lion Electrolyte Analyzer, Model GD7200CGZ · Traditional | Osmetech, Inc. | 09/29/2005SE |
| K020148 | pHoenix ISE Reagents FOR Olympus AU Chemistry SystemsCGZ · Traditional | Phoenix Diagnostics, Inc. | 02/04/2002SE |
| K013451 | Phoenoix Ise Reagents for Roche Hitachi, Models 700/900 SeriesCGZ · Traditional | Phoenix Diagnostics, Inc. | 12/18/2001SE |
More from Phoenix Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K001484 | Calibration Solution 1, Model A943-837; Calibration Solution 2, Model A943-839; Rinse…JIX · Traditional | 06/19/2000SE |
| K982501 | Electrolyte Buffer A443-325, Electrolyte Reference Reagent A443-315, CO2 Acid Reagent…JIX · Traditional | 09/01/1998SE |
| K970921 | Standard a Multiply (A540-0), Standard B Multiply (A550-0), Standard C Multiply (A560-0)JIX · Traditional | 04/08/1997SE |
| K962864 | THB Cal Standard for Il Co-Oximeters/OximetersKRZ · Traditional | 12/18/1996SE |
| K963734 | Ise Reagents for Hitachi 700 Series and 911 Clinical Chemistry SystemsCGZ · Traditional | 10/24/1996SE |
| K960085 | Ise Calibrant a & B, Ise Liquid Reagent for Paramax Clinak SystemsJIX · Traditional | 03/11/1996SE |
| K955154 | Cal 1 & Cal 2 Solution, Flush Solution KitJIX · Traditional | 12/11/1995SE |
| K951071 | Alko Slope THB Solution for Corning 280, 288 and 2500 AnalyzersKRZ · Traditional | 07/24/1995SE |
| K950902 | Alko Tonometered Saline ControlJJS · Traditional | 03/30/1995SE |
| K945966 | Alko Calibrators and Flush Solution for Il 1300 Series Ph/Blood Gas AnalyzersJIX · Traditional | 02/10/1995SE |
Questions and answers
When was Ise Reagents for Olympus Au 800/AU5200 Chemistry Systems cleared by the FDA?
Ise Reagents for Olympus Au 800/AU5200 Chemistry Systems (K972004) received a 510(k) decision of Substantially Equivalent on June 16, 1997, 17 days after the submission was received.
What is the product code of K972004?
The FDA product code is CGZ – Electrode, Ion-Specific, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.